Colorectal Cancer Mutation Detection Test & FIT-Positive Triage Test
Help evaluate and triage patients who are asymptomatic but have been screened positive by the fecal immunochemical test (FIT) and patients with clinical symptoms and/or signs of colorectal neoplasia.
Research Use Product
Research Service
Early Detection/Screening
Diagnosis
Therapy Selection
Therapy Monitoring
Introducing ColoScape™ Test
ColoScape™ Test is a multiplex real-time PCR based in vitro diagnostic assay for qualitative detection of colorectal cancer-associated mutation and methylation markers in circulating cell-free DNA (cfDNA) extracted from patient’s plasma samples (“liquid biopsy”).
Simple blood test: only 2 tubes of blood needed
Detects alterations associated with advanced adenoma and colorectal cancer
Highly sensitive for Advanced Adenoma (precancerous lesions): 62.5%
High specific for Colorectal Cancer: 93%
Who will benefit from ColoScape™?
ColoScape™ Test helps to identify the patient who is at high risk of having colorectal neoplasia and stratify those who need additional follow-up diagnostic evaluations such as colonoscopy and imaging.
Asymptomatic
For further confirmation of FIT-positive patients who are unwilling to see colonoscopy doctors
Symptomatic
For further confirmation of colorectal cancer with ColoScape™ test as a diagnostic aid
Are your patients at risk of Colorectal Cancer?
We have developed ColoScape™ to meet the need for a more sensitive test for identifying and detecting colorectal neoplasia using liquid biopsy.
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The 5-year survival rate for patients diagnosed with localized stage of Colorectal Cancer
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The 5-year survival rate for patients diagnosed at a distant stage
Detection of precancerous lesions, such as Advance Adenoma (AA), with increased sensitivity and specificity with blood draw, will help fill the huge incompliance gap for CRC screening. However, the current DNA stool and liquid biopsy tests only provide limited sensitivity for AA despite their high sensitivity for various stages of CRC.
Combined with a proprietary XNA technology and clinical data-based panel, ColoScape™ test detects as low as 0.5% low-frequency variations from blood samples and identifies 62.5% of pre-cancer patients.
The DiaCarta Offerings
PRODUCT
ColoScape™ is a CE/IVD marked product for countries with CE/IVD compliance. It could also be used as a research product in the United States.
SERVICE
ColoScape™ is available at DiaCarta CLIA as a Lab-Developed-Test (LDT).
Simple blood test: only 2 tubes of blood needed
Fast turnaround time: report ready in 3-5 business days upon sample receipt
We accept either PPO insurance or cash payment
ColoScape™ Test is more sensitive than traditional FIT-test for Advanced Adenoma (pre-cancerous) and Colorectal cancer (CRC)
Clinical Performance
ColoScape™ Test was evaluated on 52 prospectively collected whole-blood samples obtained from FIT+ patients enrolled in a CRC screening program, using colonoscopy as confirmation.
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Clinical sensitivity for Advanced Adenomas (AA)
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Clinical specificity for Advanced Adenomas (AA)
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Positive predictive value (PPV)
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Negative predictive value (NPV)
Clinical Performance
ColoScape™ Test was also evaluated on 195 plasma cfDNA samples collected from patients with confirmed advanced adenoma or various stages of CRC.
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Clinical sensitivity for Advanced Adenomas (AA)
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Clinical specificity for Advanced Adenomas (AA)
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Clinical sensitivity for Colorectal Cancer (CRC)
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Clinical specificity for Colorectal Cancer (CRC)
Resources
Disclaimer: ColoScape™ Test is intended to be complementary to and not a replacement for current recommended colorectal cancer screening protocols. Patients with abnormal results should be referred for further diagnostic evaluation (colonoscopy, imaging, etc.). The test is performed at DiaCarta laboratory as a laboratory-developed Test (LDT). It was developed and validated, and the performance characteristics determined by DiaCarta. It is not cleared or approved by the U.S. Food and Drug Administration (FDA). DiaCarta is not responsible for the clinical decision made based on the ColoScape™ test result. The DiaCarta clinical laboratory is regulated under CLIA as qualified to perform high-complexity testing.